Basket style cardiac mapping catheter having a flexible electrode assembly for detection of cardiac rhythm disorders

Abstract

A system for sensing multiple local electric voltages from endocardial surface of a heart, includes: an elongate tubular member; a plurality of flexible splines having proximal portions, distal portions and medial portions therein between; an anchor for securably affixing the proximal portions of the splines; a tip for securably affixing the distal portions of the splines; and a polymeric member including opposed a first open end and a second open end defining an open lumen therein between and an inner member surface and an outer member surface, wherein at least one of the plurality of flexible splines is at least partially disposed within the lumen of the polymeric member; a flexible electrode assembly strip with one or more exposed electrodes disposed on at least a portion of the outer surface of the polymeric member.

1. A system for sensing multiple local electric voltages from endocardial surface of a heart, comprising:
 an elongate tubular member having a lumen, a proximal end and a distal end; 
 a plurality of flexible splines having proximal portions, distal portions and medial portions therein between, wherein the splines comprise an outer surface, an inner surface and two side surfaces; 
 an anchor for securably affixing the proximal portions of the splines, wherein the anchor is securably affixed within the lumen of the elongate tubular member at the distal end of the elongate tubular member; 
 a tip for securably affixing the distal portions of the splines; and 
 a polymeric member comprising opposed a first open end and a second open end defining an open lumen therein between and an inner member surface and an outer member surface, wherein at least one of the plurality of flexible splines is at least partially disposed within the lumen of said polymeric member; 
 a flexible electrode assembly strip with one or more exposed electrodes disposed on at least a portion of the outer surface of said polymeric member; 
 wherein the flexible electrode assembly strip comprises:
 a polymeric substrate having an inner surface and an opposed outer surface; 
 said one or more exposed electrodes disposed over at least part of the outer surface of the polymeric substrate; and 
 one or more electrical traces disposed over at least a portion of the inner surface of the polymeric substrate or over at least a portion of the outer surface of the polymeric substrate, said one or more electrical traces being in electrical communication with said one or more exposed electrodes; 
 
 wherein a portion of the flexible electrode assembly transitions from the outer surface of said polymeric member towards the inner surface of said polymeric member prior to said anchor; and 
 wherein another portion of the flexible electrode assembly extends through at least a portion of said anchor and into said lumen of said elongate tubular member. 
 
     
     
       2. The system of  claim 1 , further comprising:
 a plurality of polymeric members; and 
 a plurality of flexible electrode assembly strips; 
 wherein each one of said plurality of polymeric members have at least one of said plurality of flexible electrode assembly strips; 
 wherein each one of said plurality of flexible splines is at least partially disposed within one of said plurality of polymeric members; and 
 wherein each of said plurality of splines has a different one of said plurality of polymeric members. 
 
     
     
       3. The system of  claim 1 , wherein said one or more electrical traces are disposed over at least a portion of the inner surface of the polymeric substrate and further comprising vias to provide said electrical communication between said one or more electrical traces and said one or more exposed electrodes. 
     
     
       4. The system of  claim 1 , wherein said one or more electrical traces are disposed over at least a portion of the outer surface of the polymeric substrate and further comprising a polymeric covering over the outer surface of the polymeric substrate and said electrical traces with the one or more exposed electrodes being substantially free of the polymeric covering. 
     
     
       5. The system of  claim 1 , wherein the first opposed open end of the polymeric member is secured to the distal spline portion of said at least one of the plurality of flexible splines at a position near to the distal tip and the second opposed open end of the polymeric member is secured to the proximal spline portion of said at least one of the plurality of flexible splines at a position near to the anchor. 
     
     
       6. The system of  claim 5 , wherein the first opposed open end of the polymeric member is sealingly secured to the distal spline portion at the position near to the distal tip by a seal. 
     
     
       7. The system of  claim 5 , wherein medial portions of the polymeric member between said first opposed open end and said second opposed open end of the polymeric member are not secured to said medial portions of said at least one of the plurality of flexible splines. 
     
     
       8. The system of  claim 5 , wherein at least one intermediate medial portion of the polymeric member between said first opposed open end and said second opposed open end of the polymeric member is secured to at least one intermediate portion of said medial portions of said at least one of the plurality of flexible splines. 
     
     
       9. The system of  claim 1 , wherein said one or more exposed electrodes comprise copper, gold, platinum, platinum black, platinum-iridium or and combinations thereof. 
     
     
       10. The system of  claim 1 , wherein the outer surface and the inner surface of said plurality of flexible splines are substantially flat surfaces and the two side surfaces of said plurality of flexible splines are convexly rounded surfaces. 
     
     
       11. The system of  claim 1 , wherein said one or more exposed electrodes have a substantially flat upper surface. 
     
     
       12. A system for sensing multiple local electric voltages from endocardial surface of a heart, comprising:
 an elongate tubular member having a lumen, a proximal end and a distal end; 
 a plurality of flexible splines having proximal portions, distal portions and medial portions therein between, wherein the splines comprise an outer surface, an inner surface and two side surfaces; 
 an anchor for securably affixing the proximal portions of the splines, wherein the anchor is securably affixed within the lumen of the elongate tubular member at the distal end of the elongate tubular member; 
 a tip for securably affixing the distal portions of the splines; and 
 a polymeric member comprising opposed first and second open ends defining an open lumen therein between and an inner member surface and an outer member surface, wherein at least one of the plurality of flexible splines is at least partially disposed within the lumen of said polymeric member; 
 a flexible electrode assembly strip with one or more exposed electrodes disposed on at least a portion of the outer surface of said polymeric member; 
 wherein the flexible electrode assembly strip comprises:
 a polymeric substrate having an inner surface and an opposed outer surface; 
 said one or more exposed electrodes disposed over at least part of the outer surface of the polymeric substrate; and 
 one or more electrical traces disposed over at least a portion of the inner surface of the polymeric substrate or over at least a portion of the outer surface of the polymeric substrate, said one or more electrical traces being in electrical communication with said one or more exposed electrodes; 
 
 wherein the first opposed open end of the polymeric member is secured to the distal spline portion of said at least one of the plurality of flexible splines at a position near to the distal tip and the second opposed open end of the polymeric member is secured to the proximal spline portion of said at least one of the plurality of flexible splines at a position near to the anchor; and 
 wherein medial portions of the polymeric member between said first opposed open end and said second opposed open end of the polymeric member are not secured to said medial portions of said at least one of the plurality of flexible splines. 
 
     
     
       13. The system of  claim 12 , further comprising a seal for sealingly engaging said first opposed open end of the polymeric member and said distal spline portion. 
     
     
       14. The system of  claim 12 , wherein a portion of the flexible electrode assembly extends through at least a portion of said anchor and into said lumen of said elongate tubular member. 
     
     
       15. The system of  claim 12 , further comprising:
 a plurality of polymeric members; and 
 a plurality of flexible electrode assembly strips; 
 wherein each one of said plurality of polymeric members have at least one of said plurality of flexible electrode assembly strips; 
 wherein each one of said plurality of flexible splines is at least partially disposed within one of said plurality of polymeric members; and 
 wherein each of said plurality of splines has a different one of said plurality of polymeric members. 
 
     
     
       16. The system of  claim 12 , wherein said one or more electrical traces are disposed over at least a portion of the inner surface of the polymeric substrate and further comprising vias to provide said electrical communication between said one or more electrical traces and said one or more exposed electrodes. 
     
     
       17. The system of  claim 12 , wherein said one or more electrical traces are disposed over at least a portion of the outer surface of the polymeric substrate and further comprising a polymeric covering over the outer surface of the polymeric substrate and said electrical traces with the one or more exposed electrodes being substantially free of the polymeric covering. 
     
     
       18. The system of  claim 12 , wherein said one or more exposed electrodes comprise copper, gold, platinum, platinum black, platinum-iridium or combinations thereof. 
     
     
       19. The system of  claim 12 , wherein the outer surface and the inner surface of said plurality of flexible splines are substantially flat surfaces and the two side surfaces of said plurality of flexible splines are convexly rounded surfaces. 
     
     
       20. The system of  claim 12 , wherein said one or more exposed electrodes have a substantially flat upper surface. 
     
     
       21. A system for sensing multiple local electric voltages from endocardial surface of a heart, comprising:
 an elongate tubular member having a lumen, a proximal end and a distal end; 
 a plurality of flexible splines having proximal portions, distal portions and medial portions therein between, wherein the splines comprise an outer surface, an inner surface and two side surfaces, wherein said inner and outer spline surfaces have a substantially flat portion with the substantially flat portions being parallel to one and the other, and further wherein the two side spline surfaces are convexly rounded to define a rounded-rectangular shape; 
 an anchor for securably affixing the proximal portions of the splines, wherein the anchor is securably affixed within the lumen of the elongate tubular member at the distal end of the elongate tubular member; 
 a tip for securably affixing the distal portions of the splines; and 
 a plurality of polymeric members each having opposed first and second open ends defining an open lumen therein between, wherein the polymeric members comprise an outer surface, an inner surface and two side surfaces where a cross-sectional profile of the polymeric members is elliptical to match a cross-sectional profile of the rounded-rectangular shape of the splines and is slightly larger than the cross-sectional profile of the rounded-rectangular shape of the splines and wherein each of the plurality of flexible splines is at least partially disposed within the lumen of a different one of said plurality of polymeric members; 
 a plurality of flexible electrode assembly strips each with one or more exposed electrodes disposed on at least a portion of the outer surface of each of said polymeric members; 
 wherein each of the plurality of flexible electrode assembly strips comprises:
 a polymeric substrate having an inner surface and an opposed outer surface; 
 said one or more exposed electrodes disposed over at least part of the outer surface of the polymeric substrate; and 
 one or more electrical traces disposed over at least a portion of the inner surface of the polymeric substrate or over at least a portion of the outer surface of the polymeric substrate, said one or more electrical traces being in electrical communication with said one or more exposed electrodes; 
 
 wherein a portion of each of said flexible electrode assembly strips extends through at least a portion of said anchor and into said lumen of said elongate tubular member. 
 
     
     
       22. The system of  claim 21 , wherein said one or more electrical traces are disposed over at least a portion of the inner surface of the polymeric substrate and further comprising vias to provide said electrical communication between said one or more electrical traces and said one or more exposed electrodes. 
     
     
       23. The system of  claim 21 , wherein said one or more electrical traces are disposed over at least a portion of the outer surface of the polymeric substrate and further comprising a polymeric covering over the outer surface of the polymeric substrate and said electrical traces with the one or more exposed electrodes being substantially free of the polymeric covering. 
     
     
       24. The system of  claim 21 , wherein the first opposed open end of the polymeric member is sealingly secured to the distal spline portion of said at least one of the plurality of flexible splines at a position near to the distal tip and the second opposed open end of the polymeric member is secured to the proximal spline portion of said at least one of the plurality of flexible splines at a position near to the anchor. 
     
     
       25. The system of  claim 24 , wherein medial portions of the polymeric member between said first opposed open end and said second opposed open end of the polymeric member are not secured to said medial portions of said at least one of the plurality of flexible splines. 
     
     
       26. The system of  claim 24 , wherein at least one intermediate medial portion of the polymeric member between said first opposed open end and said second opposed open end of the polymeric member is secured to at least one intermediate portion of said medial portions of said at least one of the plurality of flexible splines. 
     
     
       27. The system of  claim 21 , wherein said one or more exposed electrodes comprise copper, gold, platinum, platinum black, platinum-iridium or combinations thereof. 
     
     
       28. The system of  claim 21 , wherein said one or more exposed electrodes have a substantially flat upper surface. 
     
     
       29. A system for sensing multiple local electric voltages from endocardial surface of a heart, comprising:
 an elongate tubular member having a lumen, a proximal end and a distal end; 
 a plurality of flexible splines having proximal portions, distal portions and medial portions therein between, wherein the splines comprise an outer surface, an inner surface and two side surfaces; 
 an anchor for securably affixing the proximal portions of the splines, wherein the anchor is securably affixed within the lumen of the elongate tubular member at the distal end of the elongate tubular member; 
 a tip for securably affixing the distal portions of the splines; and 
 a plurality of polymeric members each having opposed first and second open ends defining an open lumen therein between and an outer surface and an inner surface, wherein each of the plurality of flexible splines is at least partially disposed within the lumen of a different one of said plurality of polymeric members; 
 a plurality of flexible electrode assembly strips each with one or more exposed electrodes disposed on at least a portion of the outer surface of a different one of each of said polymeric members; 
 wherein each of the plurality of flexible electrode assembly strips comprises:
 a polymeric substrate having an inner surface and an opposed outer surface; 
 said one or more exposed electrodes disposed over at least part of the outer surface of the polymeric substrate; and 
 one or more electrical traces disposed over at least a portion of the inner surface of the polymeric substrate or over at least a portion of the outer surface of the polymeric substrate, said one or more electrical traces being in electrical communication with said one or more exposed electrodes; 
 
 wherein each of the flexible electrode assembly strips is compressed into the outer surface of the different one of each of said polymeric members; and 
 wherein each of the flexible electrode assembly strips is thermally or adhesively bonded to the outer surface of the different one of each of said polymeric members.